The federal Food and Drug Administration and the Consumer Product Safety Commission have issued a warning to parents of newborns and infants who use a foam and cloth sleep positioner to keep their babies on their back in a crib while sleeping.
The commission last week warned parents to stop using the positioners, attributing 12 deaths over 13 years to the popular sleep safety item. The positioners may trap an infant between cribside and positioner and cause suffocation. Most of the infant deaths occurred after a baby rolled from a side to stomach position, the two agencies said in a statement.
The American Academy of Pediatrics has long urged parents not to use positioners.
The FDA has asked 18 manufacturers to stop making and selling positioners. If makers have information that the benefits of the positioners outweigh the risks, Sharfstein said, the FDA would like to see it.